This invention relates to a suture label which permits direct dispensing of the suture and to a tearable suture envelope that can be torn from a tear notch across the face of the envelope so as to expose the label. A suture is a strand of material suitable for suturing, with or without an attached needle or needles, used for ligating or other surgical procedures.
The packaging of many commercial products is essential to the proper end use of the product and thus forms an integral part of the overall product design. The significance of packaging is most evident in the packaging of surgical sutures. It is essential that the package protect the product and maintain sterility throughout its period of potential use. Sutures may be stored in hospitals for several years, although the usual storage time is much shorter. It is essential that the package provide rapid and positive means of identification and release the product undamaged ready for use by the surgeon. There are many sizes of sutures, and many materials of construction such as catgut or polyglycolic acid for absorbables, silk, cotton, nylon, dacron, polyethylene, polypropylene, stainless steel, insulated stainless steel and other materials for use as non-absorbables. There are several different needle types in common use including pointed straight, pointed curved, three cornered straight, three cornered curved, curved both regular and reverse cutting, and needles with side cutting edges of various types. The variations and combinations of each of these to meet the preference of many surgeons for different operative procedures means that the suture manufacturer needs to supply different suture combinations running into the thousands. The importance of positive identification and efficient, economical packaging can thus be readily appreciated.
It is also important to provide convenience to the user and limit the risk of accidently enclosing foreign items in the patient by limiting the number of extraneous packaging materials associated with use of the product in the operating theater. A count is often kept to ensure that each item is accounted for and removed from the operating field. Considering the ramifications of enclosing such material in the patient accidently during surgical procedures, it is obviously essential to minimize this hazard.
It is also important that the surgical package properly present the needles suitably oriented within the package so that the user can rapidly and reliably grip the needle with the hand or with needle forceps in the proper position for immediate use.
It is important also, to provide a standard packaging format for all suture materials to limit confusion on the part of the user during surgical procedures. Over the years a multitude of package styles has evolved that has detracted from user convenience and operating room efficiency. For purposes of storage in the hospital as well as economy of manufacture, it is highly desirable that as many suture combinations as feasible be packaged in a minimum number of different package styles and shapes and storage units. It is quite common to package 3 dozen identical sutures in a box. It is convenient to have most of the boxes about the same size and shape, so that the hospital may store them most conveniently. It is also convenient from the manufacturers stand point to be able to reduce his inventory of box sizes and to be able to use the same components for the maximum number of suture combinations in the product line.
It is essential that a package containing a surgical needle or needles, protect the suture from contact with the sharp point or cutting edge of the needle which could partially cut the suture or the package. Also the armed needle edges and point need to be protected so as to maintain their sharpness.
These requirements are so rigorous and of such importance that many different package designs have been tried. For example, see U.S. Pat. No. 3,959,947; U.S. Pat. No. 3,939,969; U.S. Pat. No. 3,876,068; U.S. Pat. No. 3,869,044; U.S. Pat. No. 3,728,829; U.S. Pat. No. 3,444,994; U.S. Pat. No. 3,202,273; U.S. Pat. No. 2,949,181; and Canadian Pat. No. 705,232. These patents are incorporated herein by reference. Generally, these patents disclose surgical suture or sutures packaged in a plastic or foil strippable envelope. Contained in the strippable envelope is an inner envelope or pouch, which is sterile. The suture strand has been formed into various configurations of coils and loops, contained in or on various retainers, labels, or reels, within the inner envelope. The suture is normally prepared for the surgeon by stripping the outer envelope and transferring the inner envelope by sterile forceps, or by projecting it across a sterile barrier, into the sterile areas of the operating room. The inner envelope is opened at the time of use.
The inner envelope and label of the present invention have advantages over these prior art patents. After tearing the inner envelope of the present invention, the label is exposed. The label can then be used for direct dispensing without extracting it from the inner envelope. Access to the suture is provided from the label by a needle protection flap which is lifted after tearing the inner envelope.
Because the inner envelope and label remain together after opening, the proliferation of packaging materials within the immediate area of the operation or other surgical procedure is reduced. Further, besides direct access to the suture with or without needles, the suture is oriented within the label and inner envelope to allow immediate use when grasped by the needle holder or by hand. This is a desired operating room and surgical procedure technique, as it reduces the amount of time between extracting the suture from the label to its actual use as a suture. Still further, in most operations and surgical procedures, the materials used for the operation or surgical procedure are counted subsequent to the operation or surgical procedure. The label and inner envelope of the present invention provide a readily identifiable and countable package. Finally, the size of the needle and the type of suture strand can be printed on the inner envelope. This provides ready identification in a surgical procedure where more than one size and type of suture is used. The possibility of a mix-up in the sizes and types is also reduced because the suture is directly dispensed from the label contained in the inner envelope.